BaroPace, Inc. Marks Milestone as Initial Patient Enrolls in Trial Targeting Non-Pharmacologic Treatment of Hypertension and Heart Failure
Wednesday, August 23, 2023
BaroPace, an innovative medical device company that specializes in the development of PressurePace™, a real-time physiological control software and hardware aimed at regulating cardiac pacemakers, has reached a significant milestone. The company has commenced its inaugural human clinical trial, named RelieveHFpEF-II, and successfully enrolled its first patient. The trial aims to revolutionize the treatment approach for resistant hypertension and heart failure with preserved ejection fraction (HFpEF) by leveraging the capabilities of PressurePace™.
PressurePace™, a proprietary closed-loop pacemaker control algorithm, represents a breakthrough by dynamically adapting a cardiac pacemaker's functioning based on the patient's blood pressure. This advancement holds the potential to introduce an entirely new perspective to managing HFpEF for patients.
The clinical trial, which involves sixteen subjects in India, follows a multicenter, double-blind, crossover design to evaluate the safety and effectiveness of PressurePace™ in comparison to conventional pacemaker therapy. The primary objectives of the trial include assessing safety, measuring improvements in exercise performance, and gauging the impact on patients' quality of life using the Minnesota Living with Heart Failure Questionnaire. Secondary endpoints encompass aspects like blood pressure control, occurrences of atrial fibrillation, and the frequency of hospitalizations.
The trial's unique structure consists of an initial one-week baseline assessment phase, followed by a randomized three-week treatment phase. During this treatment phase, subjects are assigned to either standard pacemaker therapy or the innovative PressurePace™ approach, which is colloquially referred to as "BaroPacing." Notably, the BaroPacing group receives programmed adjustments twice daily in a home setting, while the standard treatment group undergoes placebo programming.
This achievement underscores BaroPace's strong commitment to pioneering non-pharmacological solutions that enhance the quality of life and longevity of individuals facing the challenges of resistant hypertension and HFpEF two critical areas within cardiovascular medicine.